Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-8)
研究概览
简要总结
The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 16-17 years old
- •Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5-19, inclusive, assessed at screening/baseline
- •Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
- •Available and committed to engage with the program and complete assessments for an 8-week duration
- •Able to read and write in English
- •U.S. resident
- •Regular, stable dose of antidepressant medications for (e.g. escitalopram/Lexapro, fluoxetine/ Prozac) for at least 60 days at screening with no plans to change medication/dose throughout the study
- •If currently receiving psychotherapy, then must be in therapy for at least 4 weeks at screening with no changes planned for the duration of the study
- •Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
排除标准
- •Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
- •Lifetime diagnosis of bipolar disorder
- •Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
- •Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
- •History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
- •Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
- •Previous Woebot Application use
研究组 & 干预措施
W-GenZD
W-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.
干预措施: W-GenZD (Device)
Psychoeducation Control
The control for this study is the scheduled delivery of digital psychoeducational files (PDFs). The PDFs were selected to provide information on depression, anxiety and stress, as well as outline common coping skills.
结局指标
主要结局
Patient Health Questionnaire (PHQ-8)
时间窗: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
次要结局
- Usage Rating Profile Intervention (URPI)(Post-treatment (8 weeks from baseline))
- Mood change ratings after CBT skill application(Post-treatment (8 weeks from baseline))
- Working Alliance Inventory (WAI-SR)(Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks)
- Mental Health Self-Efficacy Scale (MHSE)(Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks)
- Number of active application days(Post-treatment (8 weeks from baseline))
- Satisfaction ratings of psychoeducational materials(Post-treatment (8 weeks from baseline))
- Generalized Anxiety Disorder (GAD-7)(Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks)
- Client Satisfaction Questionnaire (CSQ)(Post-treatment (8 weeks from baseline))
- Number of application messages sent per week(Post-treatment (8 weeks from baseline))